Drug delivery device with an improved piston rod

ABSTRACT

An improved drug delivery device is provided having a piston rod that incorporates on its proximal end at least one guidepost that is configured for transmitting axial and rotational forces from a drive mechanism. The device comprises a drug delivery device housing and a medicament contained in the drug delivery device housing.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/258,575, filed Dec. 6, 2011, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. §371 of International Application No.PCT/EP2010/053968 filed Mar. 26, 2010, which claims priority to EuropeanPatent Application No. 09004570.9 filed on Mar. 30, 2009 and U.S.Provisional Patent Application No. 61/169,849 filed on Apr. 16, 2009.The entire disclosure contents of these applications are herewithincorporated by reference into the present application.

FIELD OF THE INVENTION

The present invention relates to pen-type injectors, that is toinjectors of the kind that provide for administration by injection ofmedicinal products from a multi-dose cartridge. In particular, thepresent invention relates to such injectors where an improved piston rodhaving guideposts manages high dispensing loads transmitted by a drivemember or mechanism.

BACKGROUND

Pen type drug delivery devices have application where regular injectionby persons without formal medical training occurs. This is increasinglycommon among patients having diabetes where self-treatment enables suchpatients to conduct effective management of their disease.

Diabetes has been shown to cause certain problems. For example, peoplewith diabetes can get high blood pressure, kidney disease, nerve damage,heart disease, and even in certain circumstances blindness. The damagecaused by these problems may occur in patients whose blood sugar hasbeen out of control for years. Keeping blood sugar under control, by wayof effective insulin administration, is one method that can help preventthis damage from occurring.

In addition, people with diabetes can go into “diabetic coma” if theirblood sugar is too high. They can also develop blood sugar that is toolow (i.e, hypoglycemia) if they don't get enough food, or they exercisetoo much without adjusting insulin or food. Both diabetic coma andhypoglycemia can be very serious, and even fatal, if not treatedquickly. Closely watching blood sugar, being aware of the early signsand symptoms of blood sugar that is too high or too low, and treatingthose conditions early can prevent these problems from becoming tooserious.

Pen type drug delivery devices have been designed and developed to helppatients suffering from diabetes so as to prevent such problems fromoccurring. The circumstances identified above highlight a number ofdesign considerations and criteria for drug delivery devices, especiallythose that may be used to treat diabetes. As just one example, onerequirement is that the drug delivery device must be robust inconstruction. The drug delivery device must also be easy to use both interms of the drug delivery device manipulation and understanding of thedevice's operation. Diabetics have to inject themselves repeatedly withinsulin solution and the volume of insulin to be injected may vary frompatient to patient and even from injection to injection. For at leastthis reason, certain diabetics may require drug delivery devices thatallow the patient to inject successive measured dosages of the same orperhaps different preset volumes of insulin solution accurately and withminimum dexterity challenges. This presents a further design challengesince, in the case of certain diabetics, users may have impaired visionand/or may be physically infirm with limited dexterity.

Pen-type injectors are well known and typically each use some form of apiston rod to axially drive or push a rubber stopper in a cartridgetowards the distal end of the injector to dispense medicament from thecartridge through an attached needle. Such injectors have applicationwhere regular injection by persons without formal medical trainingoccurs. This is increasingly common amongst those having diabetes whereself-treatment enables such persons to conduct effective management oftheir diabetes.

These circumstances set a number of requirements for pen-type injectorsof this kind. The injector must be robust in construction, yet easy touse both in terms of the manipulation of the parts and understanding bya user of its operation. In the case of those with diabetes, many userswill be physically infirm and may also have impaired vision. Where theinjector is to be disposable rather than reusable, the injector shouldbe inexpensive to manufacture and easy to dispose of (preferably beingsuitable for recycling).

One problem frequently encountered when using these pen-type is highdispensing loads that can be caused by a blocked or clogged needle, orwhere the user forgets to attach a needle, or where the user appliesexcessive force during the injection, typically by injecting too fast. Adrive member or sleeve ultimately transmits these high dispensing loadsto the proximal end of the piston rod, which in turn transmits theforces to the piston or bung in a cartridge of medicament. Such loadsmanifest themselves as rotational and/or axial forces and can causejamming of the device and even shearing or breaking of the piston rod.

OBJECT OF THE INVENTION

It is therefore an object of the invention to provide an improved pistonrod and an improved drug delivery device which has a reduced risk ofjamming of the device or destroying the piston rod.

SUMMARY

Our invention solves these problems by using guideposts, pins, pegs,followers or the like structures that protrude outwardly from theproximal end of a piston rod and are designed to interact with acorresponding groove in a drive sleeve to transmit forces from a drivemechanism to the piston rod. These and other advantages will becomeevident from the following more detailed description of the invention.

According to an exemplary embodiment, a drug delivery device comprises adevice housing and a medicament contained in the device housing. A drivemechanism is positioned in the housing for transmitting axial and/orrotational force to a piston rod comprising an elongated member having adistal end and a proximal end. The shape of rod is not critical to ourinvention, likewise the material of construction is not important,except that the rod must be able to drive or push a rubber stopper orbung in a cartridge of medicament towards the distal end duringinjection of a set dose. Preferably, the proximal end of the piston rodshould be made of low friction type plastics so that the transfer offorces from the drive member is not dissipated by friction losses.

A preferred shape of the improved piston rod of our invention isgenerally circular and is fabricated from a polymeric material throughmolding or machining A metallic material may also be used to fabricateall or part of the piston rod. The proximal end of the piston rodinteracts with a drive sleeve and has at least one guidepost extendingoutwardly from the elongated member and is configured to engage acooperating or corresponding groove in a drive member and fortransmitting axial or rotational forces from the drive member. Whenmultiple guideposts are used, the orientation of the posts relative toeach other can be any design that facilitates the transfer of force(axial and/or rotational) from the drive member to the piston rod.Non-axial alignment of the posts may provide strength benefits.Preferably, the guideposts fall in a path that corresponds to one ormore grooves or slots on or in the drive member.

In another embodiment the invention comprises at least two sets of twoor more guideposts, where the guideposts are in axial alignment witheach other. These posts can be any geometric shape or a mix of geometricshapes. Preferably, the posts are circular or oblong in shape andconfigured for transmitting axial and/or rotational forces from a drivemechanism having at least one drive member having a correspondinginternal groove with a pitch P. These posts, pegs or pins provide auniform contact angle with respect to the groove in the drive member toreduce friction and the risk of jamming during injection. Anotherbenefit is that the guideposts are simpler to manufacture as compared toa thread, thus reducing tooling costs and are easier to control andinspect the quality.

In a preferred embodiment, there are two sets of guide-posts located onopposing sides of the proximal end of the rod, where each set containsat least three guide-posts circular in shape. In some cases it might beadvantageous to include threads on the distal end of the piston rod.When a threaded distal end is used, it is preferred that these threadson the distal end of the piston rod are oppositely disposed to thegroove of the drive sleeve.

A drive mechanism is connected either directly or indirectly with theproximal end of the piston rod and in a preferred embodiment is directlyconnected to the guideposts through a groove or grooves of correspondingdimension located on or in a drive sleeve member. Preferably thegroove(s) in the drive member are a square or buttress type design.

In an alternative arrangement, a pen type drug delivery device comprisesa device housing having a distal end for mounting a needle assembly anda proximal end comprising a dose dial grip. A cartridge is contained inthe housing, which contains a medication and a stopper. The improvedpiston rod of our invention acts upon the stopper to expel medicationfrom the cartridge during dose delivery. Preferably, the proximal end ofthe piston rod and/or the groove(s) in the drive member are made usingmaterials exhibiting low friction qualities.

These as well as other advantages of various aspects of Applicants'proposed drug delivery device will become apparent to those of ordinaryskill in the art by reading the following detailed description, withappropriate reference to the accompanying drawings.

The term “medication”, as used herein, means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, anantibody, a hormone or an oligonucleotide, or a mixture of theabove-mentioned pharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exedin-3 or exedin-4 or an analogue or derivative ofexedin-3 or exedin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N—(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N—(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(w-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

-   H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or-   des Pro36 [Asp28] Exendin-4(1-39),-   des Pro36 [IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),-   des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),    wherein the group-Lys6-NH2 may be bound to the C-terminus of the    Exendin-4 derivative;    or an Exendin-4 derivative of the sequence-   H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,-   des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,-   des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,-   H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-Lys6-NH2,-   H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]    Exendin-4(1-39)-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]    Exendin-4(1-39)-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-NH2,-   des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2,-   H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]    Exendin-4(1-39)-(Lys)6-NH2;    -   or a pharmaceutically acceptable salt or solvate of any one of        the afore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane such as hyaluronicacid, a heparin, a low molecular weight heparin or an ultra lowmolecular weight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are described herein with reference to thedrawings, in which:

FIG. 1 illustrates a sectional view of a first embodiment of the drugdelivery device in accordance with the one arrangement of the device ina first, cartridge full, position;

FIG. 2 illustrates a sectional view of the drug delivery device of FIG.1 in a second, maximum first dose dialed, position;

FIG. 3 shows a perspective view of one embodiment of a piston rodaccording to one embodiment of the invention having circular guideposts; and

FIG. 4 shows a perspective view of another embodiment of a piston rodaccording to another embodiment of the invention having oblong shapedguideposts.

DETAILED DESCRIPTION

Referring first to FIGS. 1 and 2, there is shown a drug delivery device1 in accordance with the one arrangement in a plurality of operatingpositions: for dose setting and for dose administration or injection.The drug delivery device 1 comprises a housing having a first cartridgeretaining part 2, and second main (exterior) housing part 4. A first endof the cartridge retaining means 2 and a second end of the main housing4 are secured together by retaining features. In this illustratedarrangement, the cartridge retaining means 2 is secured within thesecond end of the main housing 4.

A cartridge 8 from which a number of doses of a medicinal product may bedispensed is provided in the cartridge retaining part 2. Preferably, thecartridge 8 contains a type of medicament that must be administeredoften, such as once or more times a day. One such medicament is insulin.A piston 10 is retained in a first end of the cartridge 8. A removablecap 3 is releasably retained over a second end of the cartridgeretaining part 2.

The dose setting mechanism of the drug delivery device illustrated inFIGS. 1-2 may be utilized as either a disposable or reusable drugdelivery device. Where the drug delivery device comprises a disposabledrug delivery device, the cartridge cannot be removed from the devicewithout destroying the device. Alternatively, where the drug deliverydevice comprises a reusable drug delivery device, the cartridge isremovable and may be removed from the device without destroying thedevice. In the drug delivery device 1 illustrated in FIGS. 1-2, thisdrug delivery device is illustrated as a disposable drug delivery.However, those of ordinary skill in the art will recognize that the dosesetting mechanism could also be used on reusable drug delivery devicesas well.

In use, the removable cap 3 can be replaced by a user with a suitableneedle unit (not shown). Such needle unit may be screwed onto a distalend of the housing or alternatively may be snapped onto this distal end.A replaceable cap 14 is used to cover the cartridge retaining part 2extending from the main housing 4. Preferably, the outer dimensions ofthe replaceable cap 14 are similar or identical to the outer dimensionsof the main housing 4 so as to provide an impression of a unitary wholewhen the replaceable cap 14 is in position covering the cartridgeretaining part 2.

Referring also to FIGS. 3 and 4, a first helical groove 19 extends froma first end of a piston rod 20. In one arrangement, the piston rod 20 isof generally circular in cross section however other arrangements mayalso be used. The first end of the piston rod 20 (the distal end of thepiston rod 20) extends through the threaded opening 18 in the body 4. Apressure foot 22 is located at the first end or distal end of the pistonrod 20. The pressure foot 22 is disposed to abut a second end of thecartridge piston 10. On the second end of piston rod 20 are guideposts24, shown in FIGS. 1 & 2 for that embodiment as circular knobs or pins(also see FIG. 3), which extend radially outward along a singlelongitudinal axis 50 from the proximal end of the piston rod 20. Inanother embodiment shown in FIG. 4, guideposts 24 are oblong in shape.Regardless of the shape of the guideposts, they are used to communicatewith and transmit axial and/or rotational forces from drive sleeve 30 topiston rod 20 and eventually to cartridge piston 10.

The guideposts or guide ribs can be designed in any geometric shape orcombination of shapes. Preferred shapes are circular guide posts 24(FIG. 3) or oblong guide posts 24′ (FIG. 4). The upper most post may bea complete form as shown in the drawings or may be a partial ortruncated shape form, for example a half circle. The geometry of theseguideposts is selected to withstand high dispensing loads. Because theposts or ribs 24, 24′ contact the drive sleeve at single defined pointsthis will reduce the likelihood of jamming of the drive mechanism thatcan be caused by mismatched thread forms. The pitch of the guide ribs24, 24′ is easy to specify and monitor during manufacturing and criticaldimensions can be measured point-to-point.

A drive sleeve 30 extends about the piston rod 20. The drive sleeve 30is generally cylindrical. The drive sleeve 30 is provided at a first endwith a first radially extending flange 32. A second radially extendingflange 34 is provided spaced a distance along the drive sleeve 30 fromthe first flange 32. An intermediate helical groove 36 is provided on anouter part of the drive sleeve 30 extending between the first flange 32and the second flange 34. A helical groove 38 extends along the internalsurface of the drive sleeve 30. The guideposts 24 of the piston rod 20are adapted to work within the helical groove 38 of drive member 30.

A first end of the first flange 32 is adapted to conform to a secondside of the insert 16. A part nut 40 is located between the drive sleeve30 and the main housing 2, disposed between the first flange 32 and thesecond flange 34. In the illustrated arrangement, the part nut 40comprises a half-nut. The part nut 40 has an internal helical groovematching the intermediate helical groove 38 of the drive sleeve 30. Inone preferred arrangement, the outer surface of the part nut 40 and aninternal surface of the main housing 4 are keyed together by way ofsplines 6 to prevent relative rotation between the part nut 40 and themain housing 4, while allowing relative longitudinal in movement betweenthese two components.

A dose dial sleeve 70 is provided outside of drive member 30 and clutch60 and radially inward of the main housing 4. Towards the second end 64of the clutch means 60 there is located a radially inwardly directedflange 62. The dose dial sleeve 70 comprises a distal end and a proximalend. A helical groove 74 is provided about an outer surface 72 of thedose dial sleeve 70. The main housing 4 is provided with a window 44through which a part of an outer surface 72 of the dose dial sleeve 70may be viewed. The main housing 4 is further provided with a helical rib46, adapted to be seated in the helical groove 74 on the outer surfaceof the dose dial sleeve 70. In one preferred arrangement, the helicalrib 46 extends for a single sweep of the inner surface of the mainhousing 4.

Returning to FIGS. 1-2, a dose dial grip 76 is disposed about an outersurface of the second end of the dose dial sleeve 70. An outer diameterof the dose dial grip 76 preferably corresponds to the outer diameter ofthe main housing 4. The dose dial grip 76 is secured to the dose dialsleeve 70 to prevent relative movement between these two components. Anannular recess 80 located in the second end of the dose dial grip 76extends around the opening 78. A button 82 of generally “T” section isprovided at a second end of the device.

To dial a dose in the arrangement illustrated in FIGS. 1-2, a user holdsthe main housing 4 in his or her left hand and uses the right hand torotate the dose dial grip 76 in a direction away from the user. With theclutch 60 engaged, the drive sleeve 30, the clutch 60 and the dose dialsleeve 70 rotate with the dose dial grip 76 towards the user. Audibleand tactile feedback of the dose being dialed is provided by a clickerand the clutch 60. The helical groove 74 on the dose dial sleeve 70 andthe helical groove 38 in the drive sleeve 30 have the same lead. Thisallows the dose dial sleeve 70 to extend in a proximal direction awayfrom the main housing 4 (See FIG. 2). In this manner, the drive sleeve30 climbs the piston rod 20 at the same rate. Rotation of the piston rod20 is prevented due to the opposing directions of the overhauled anddriven threads on the piston rod 20. The part nut 40, keyed to the mainhousing 4, is advanced along the intermediate thread 36 by the rotationof the drive sleeve 30.

A visual indication of the dose that may be dialed, for examplereference numerals or a scale, may be provided on the outer surface 72of the dose dial sleeve 70 and viewed through window 44.

Should a user inadvertently dial beyond a desired dosage, the drugdelivery device allows the dosage to be dialed down without dispense ofmedicinal product from the cartridge. In order for the user to dial downthe dosage, the dose dial sleeve 70 is rotated in a direction towardsthe user and the dose dial grip 76 is counter rotated. This causes thesystem to act in reverse. When the desired dose has been dialed, theuser may then dispense this dose by depressing the button 82. As theuser depresses the button 82, this displaces the clutch 60 axially withrespect to the dose dial sleeve 70. However the clutch 60 remains keyedin rotation to the drive sleeve 30. The dose dial sleeve 70 andassociated dose dial grip 76 are now free to rotate (guided by thehelical rib 46 located in helical groove 74).

The drive sleeve 30 is prevented from rotating with respect to the mainhousing 4 though it is still free to move axially with respect thereto.The longitudinal axial movement of the drive sleeve 38 causes the pistonrod 20 to rotate through the opening 18 in the insert 16, thereby toadvance the piston 10 in the cartridge 8.

Exemplary embodiments of the present drug delivery device have beendescribed. Those skilled in the art will understand, however, thatchanges and modifications may be made to these embodiments withoutdeparting from the true scope and spirit of the presently proposed drugdelivery device, which is defined by the claims. In particular, theimproved piston rod of our invention can be used in a number of varyingand different drug delivery device designs.

The invention claimed is:
 1. A drug delivery device comprising: ahousing; a drive mechanism positioned in the housing; and a piston rodoperatively connected to a drive member, where the piston rod comprisesat least two sets of two or more guideposts extending outwardly from thepiston rod, wherein at least one of the at least two sets of two or moreguideposts has guideposts configured as a post, peg, or pin having asingle longitudinal axis projecting radially outward and are configuredfor transmitting axial and rotational forces from the drive member,where the at least two sets of guideposts are located on opposing sidesof a proximal end of the piston rod and the guideposts are aligned in apath that coincides with a groove on an inside surface of the drivemember, where the groove has a first lead.
 2. The drug delivery deviceof claim 1 where the piston rod further comprises a distal end having athreaded outer surface, where the threaded outer surface is separatefrom and does not overlap the proximal end containing the guideposts. 3.The drug delivery device of claim 2 where the threaded outer surface isthreadedly engaged with a threaded opening that is rotationally andaxially fixed relative to the housing such that the piston rod rotatesthrough the threaded opening and moves axially in a distal directionduring dose delivery.
 4. The drug delivery device of claim 1 where thepiston rod is generally circular in cross-section.
 5. The drug deliverydevice of claim 1 where the guideposts are not in axial alignment witheach other.
 6. The drug delivery device of claim 1 where the piston rodfurther comprises a distal end having a threaded outer surface having asecond lead that is opposite the first lead, where the first and secondleads are configured such that the piston rod will not rotate duringdose setting.
 7. The drug delivery device of claim 1 where the pistonrod further comprises a longitudinal axis, the guideposts are oblong inshape, and are oriented parallel to the longitudinal axis.
 8. The drugdelivery device of claim 1 where the housing contains a cartridge ofinsulin.
 9. The drug delivery device of claim 1 where the housing isconfigured to accept a removable cap releasably retained over a distalend of the housing.
 10. A pen type drug delivery device comprising: ahousing comprising a non-removable cartridge of medicament and a drivemechanism, where the drive mechanism comprises a piston rod operativelyconnected to a drive member through engagement with a proximal end ofthe piston rod having at least two sets of two or more guidepostsextending outwardly, wherein each guidepost is configured as a post,peg, or pin having a single longitudinal axis projecting radiallyoutward from the proximal end and are configured for transmitting axialand rotational forces from the drive member, where the at least two setsof guideposts are located on opposing sides of the proximal end of thepiston rod and the guideposts are aligned in a path that coincides witha groove on an inside surface of the drive member, where the groove hasa first lead.
 11. The drug delivery device of claim 10 where the pistonrod has a distal end having a threaded outer surface, where the threadedouter surface is separate from and does not overlap with the guideposts.